NASDAQ: CAPR Investor Alert: Lawsuit filed against Capricor Therapeutics, Inc. in effort to Recover Investor losses

An investor, who purchased shares of Capricor Therapeutics, Inc. (NASDAQ: CAPR), filed a lawsuit over alleged violations of Federal Securities Laws by Capricor Therapeutics, Inc. in connection with certain allegedly false and misleading statements.

Investors who purchased shares of Capricor Therapeutics, Inc. (NASDAQ: CAPR) have certain options and for certain investors are short and strict deadlines running. Deadline: September 28, 2026 NASDAQ: CAPR investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

San Diego, CA based Capricor Therapeutics, Inc., a clinical-stage biotechnology company, engages in the development of transformative cell and exosome-based therapeutics for treating duchenne muscular dystrophy (DMD) and other diseases with unmet medical needs in the United States. Capricor Therapeutics, Inc. (NASDAQ: CAPR) reported that its Net Loss increased from $40.46 million in 2024 to $100.11 million in 2025.

On July 27, 2026, before the market opened, the FDA allegedly released briefing documents ahead of its July 29 advisory committee meeting for the BLA. According to the complaint, the briefing documents explained that Capricor made changes to the pre-specified statistical analysis plan ("SAP") and that the final version "was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon." The final version of the statistical analysis plan was allegedly created one day before the data was unblinded, and the FDA commented that the "FDA does not consider the conversion of raw change to percent change and then back to raw change to have been scientifically justified, as it adds complexity and reduces accuracy." The FDA allegedly further stated that it "considers [Capricor's] analyses based on the post-study SAP versions to be post-hoc and exploratory." The complaint further alleges that the briefing documents concluded "the benefit-risk assessment for [D]eramiocel appears unfavorable in the absence of evidence of effectiveness."

That same day, Capricor Therapeutics, Inc. allegedly provided "an update," stating that "'Capricor has engaged fully and transparently with the FDA throughout the review process'" and that "'[i]t is critical to understand that the post-hoc analyses in the FDA's briefing materials rely on SAP version 1.1, an unsigned incomplete internal draft which became obsolete with the addition of cohort B and did not include content specifically requested by the FDA.'" The Capricor class action lawsuit further alleges that Cantor Fitzgerald published an investor note that same day, stating the FDA's "briefing documents paint an ugly picture" and "raise several concerns and make allegations about the integrity of data collecting."

On July 29, 2026, the advisory committee allegedly met to discuss the Deramiocel BLA. The next day, Medscape reported that the panel relied on SAP version 1.1 as the "prespecified plan" and, in a non-binding 9-3 vote, the panel "concluded that the available evidence does not support the efficacy of deramiocel for treating DMD-associated cardiomyopathy."

Shares of Capricor Therapeutics, Inc. (NASDAQ: CAPR) declined from $36.82 per share on April 20, 2026, to as low as $2.96 per share on July 30, 2026.

The plaintiff claims that between December 17, 2025 and July 26, 2026, the defendants made false and/or misleading statements and/or failed to disclose that Capricor Therapeutics, Inc. adopted changes to the pre-specified statistical analysis plan used to analyze clinical data for Deramiocel, that the FDA had not agreed to those changes before Capricor Therapeutics, Inc. resubmitted the Deramiocel Biologics License Application ("BLA"), that as a result, there was a significant risk that the FDA could conclude the clinical results did not provide substantial evidence of effectiveness of Deramiocel, and that as a result of the foregoing, there was a substantial risk to regulatory approval of Deramiocel for the treatment of Duchenne muscular dystrophy.

Those who purchased shares of Capricor Therapeutics, Inc. (NASDAQ: CAPR) have certain options and should contact the Shareholders Foundation.

Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities lawsuits, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

This release was published on openPR.